Archives: Agenda

The End of Fragmented Clinical Data & Decision-Making

  • Explore what becomes possible when clinical data and decisions are connected across study design, country strategy, feasibility, and site selection
  • Hear the Novo Nordisk + H1 story and how the organizations are working together toward a more connected clinical development ecosystem
  • Learn how to move beyond fragmented systems, spreadsheets, and data sources toward a trusted foundation that helps teams make faster, more informed decisions
  • Discover how connecting sponsor intelligence with site-level insights and feedback can strengthen feasibility and site selection while reducing disconnects across the trial lifecycle
  • See why connected, mastered data is critical to unlocking the potential of AI in clinical development, and why the future requires more than another point solution

Mapping Nordic R&D Innovation and the Next Wave of Drug Development

  • Identify where Nordic R&D innovation is concentrating across therapy areas, development stages and emerging modalities
  • Compare Denmark, Sweden, Finland and Norway to reveal distinct innovation profiles and emerging areas of specialisation
  • Benchmark Nordic R&D against the global pipeline to identify where the region is over-indexing and which therapeutic areas and emerging modalities could shape the next wave of drug development

Making Clinical Trial Data Work Together and Improving Visibility Across Systems Through Real-World Case Studies

  • Exploring why, in fully outsourced clinical trial models, visibility across data systems can be less a technology question than a process one
  • Understanding where data signals can fall through the gaps when multiple CROs and vendors have their own internal processes, review cadences and timelines
  • Case study: a pharmacokinetic protocol deviation that never reached the sponsor because it fell between chairs in the communication chain
  • Case study: a screen failure cleaning exercise where a site misinterpretation of instructions led to an irreconcilable discrepancy
  • Exploring how stronger oversight frameworks and clearer agreement on what is expected, and from whom, could prevent these issues
  • Asking what we should be considering before adopting a new digital tool – recognising that a tool can integrate systems, but not always processes

From Patient Experience to Digital Measures: Capturing What Matters and Keys to Successful Implementation in Clinical Trials

  • How patient centered digital measures can capture meaningful changes in health and daily life that traditional, episodic clinical assessments may miss
  • How continuous, real-world wearable data can help assess whether improvements during standardized in-clinic tests translate into meaningful changes in patients’ daily live
  • Real world case examples demonstrating how fit for purpose digital measures can reveal treatment signals, functional changes, and patient relevant outcomes that standard approaches may not fully capture
  • Why successful patient-centered digital measurement requires thoughtful study design, fit-for-purpose algorithms, continuous compliance monitoring, and high-quality data
  • Practical guidance for advancing digital measures from exploratory use toward clinically meaningful endpoints while maintaining patient relevance throughout clinical development

From Study Design to Operational Reality: Making Trials Work at Conception

  • Exploring why protocol amendments, slow enrolment and late feasibility surprises are often failures of execution rather than science
  • Applying real-world operational evidence to trial design decisions before problems surface
  • Identifying execution risks early to design more predictable, scalable trials
  • Including a live demonstration of Aika, Biorce’s AI-driven clinical trials assistant